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Sumavel DosePro

Generic Name: sumatriptan (injection) (SOO ma TRIP tan)
Brand Names: Alsuma, Imitrex, Imitrex Statdose, Imitrex Statdose Refill, Sumavel DosePro, Zembrace SymTouch

What is Sumavel DosePro?

Sumavel DosePro (sumatriptan) is a headache medicine that narrows blood vessels around the brain. Sumatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Sumavel DosePro is used to treat migraine headaches and cluster headaches in adults. Sumavel DosePro will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Sumavel DosePro should not be used to treat a common tension headache or a headache that causes loss of movement on one side of your body. Use this medicine only if your condition has been confirmed by a doctor as migraine headaches.

Important information

You should not use Sumavel DosePro if you have ever had heart disease, coronary artery disease, blood circulation problems, Wolff-Parkinson-White syndrome, uncontrolled high blood pressure, severe liver disease, a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches.

Do not use Sumavel DosePro if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Do not use Sumavel DosePro within 24 hours before or after using another migraine headache medicine..

Before using this medicine

You should not use Sumavel DosePro if you are allergic to sumatriptan, or if you have ever had:

  • heart disease, heart attack, or stroke (including "mini-stroke");

  • coronary artery disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;

  • circulation problems affecting your legs, arms, stomach, intestines, or kidneys;

  • a heart disorder called Wolff-Parkinson-White syndrome;

  • uncontrolled high blood pressure;

  • severe liver disease; or

  • a headache that seems different from your usual migraine headaches.

Do not use Sumavel DosePro if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

To make sure Sumavel DosePro is safe for you, tell your doctor if you have ever had:

  • liver or kidney disease;

  • epilepsy or other seizure disorder;

  • high blood pressure, a heart rhythm disorder; or

  • risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Sumavel DosePro can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medicine.

It is not known whether Sumavel DosePro will harm an unborn baby. Tell your doctor if you are pregnant. Your name may need to be listed on a sumatriptan pregnancy registry.

Sumatriptan can pass into breast milk, but effects on the nursing baby are not known. To avoid exposing your baby to sumatriptan in breast milk, do not breast-feed for 12 hours after using an injection. If you use a breast pump during this time, throw out any milk you collect.

Sumavel DosePro is not approved for use by anyone younger than 18 years old.

How should I use Sumavel DosePro?

Use Sumavel DosePro exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Overuse of migraine headache medicine can actually make your headaches worse.

A Sumavel DosePro dose is delivered into your stomach area (abdomen), or thigh. Do not deliver Sumavel DosePro into the arm or other body parts.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use Sumavel DosePro as soon as you notice headache symptoms, or after an attack has already begun.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to see if you have any serious side effects.

Sumavel DosePro is a needle-free injector device . Each vial, cartridge, or needle-free device is for one use only.

After using a dose: If your headache does not completely go away after the dose, call your doctor before using a second Sumavel DosePro. If your headache goes away and then comes back, you may use a second dose if it has been at least one hour since your first dose. Do not use more than two (2) doses of Sumavel in 24 hours. If your symptoms do not improve, contact your doctor before using any more doses.

Store Sumavel DosePro at room temperature away from moisture, heat, and light. Throw away any unused medicine after the expiration date on the label has passed.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include tremors, skin redness, scabs or scaly skin where you injected the medicine, weakness, lack of coordination, breathing problems, blue-colored lips or fingernails, vision problems, seizure (convulsions), or loss of movement in any part of your body.

What should I avoid while using Sumavel DosePro?

Do not use Sumavel DosePro within 24 hours before or after using another migraine headache medicine, including:

  • sumatriptan tablets or nasal spray, almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or

  • ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Sumavel DosePro may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Sumavel DosePro side effects

Get emergency medical help if you have signs of an allergic reaction to Sumavel DosePro: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Sumavel DosePro and call your doctor if you have:

  • sudden and severe stomach pain and bloody diarrhea;

  • severe chest pain, shortness of breath, irregular heartbeats;

  • a seizure (convulsion);

  • blood circulation problems in your legs or feet - cramps, tight or heavy feeling, numbness or tingling, muscle weakness, burning pain, cold feeling, color changes (pale or blue), hip pain;

  • dangerously high blood pressure - severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety;

  • heart attack symptoms - chest pain or pressure, tightness or pain spreading to your jaw or shoulder, nausea, sweating;

  • signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or

  • high levels of serotonin in the body - agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Common Sumavel DosePro side effects may include:

  • numbness or burning sensation;

  • pressure or heavy feeling in any part of your body;

  • dizziness, drowsiness, feeling weak or tired;

  • neck pain or stiffness;

  • flushing (warmth, redness, or tingly feeling); or

  • pain, redness, bleeding, swelling, or bruising where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects (in more detail)

What other drugs will affect Sumavel DosePro?

Using this medicine while you are using certain other medicines can cause high levels of serotonin to build up in your body, a condition called "serotonin syndrome," which can be fatal. Tell your doctor if you also use:

  • medicine to treat depression;

  • medicine to treat a psychiatric disorder;

  • a narcotic (opioid) medication; or

  • medicine to prevent nausea and vomiting.

This list is not complete. Other drugs may interact with sumatriptan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Sumavel DosePro.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Sumavel DosePro only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2017 Cerner Multum, Inc. Version: 8.01. Revision Date: 2017-09-25, 7:20:05 AM.

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